跳至主要内容
临床试验/NCT05478759
NCT05478759进行中(未招募)不适用

Innovative Multimodal and Attention Training to Improve Emotion Communication in Veterans With TBI and PTSD

VA Office of Research and Development2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
16
试验地点
2
主要终点
Community Reintegration of Service Members, assessing change

研究概览

简要总结

Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Currently there are no interventions for emotion recognition in Veterans with mTBI and PTSD, and interventions for severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise but lacked attention training that is an essential component in recognizing emotions in our daily lives. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a study is needed to determine the effectiveness of a MMART combined with attention training.

详细描述

Background. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Currently there are no interventions for emotion recognition deficits in Veterans with mTBI and PTSD, and interventions conducted in civilians with severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise with significant improvement on the Florida Affect Battery (FAB) but lacked attention training that is an essential component in recognizing rapidly changing emotions in our everyday lives. Attention training using Brain HQ targets the required attention factors underlying emotion recognition. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a randomized controlled trial is needed to determine the effectiveness of an innovative MMART combined with attention training to improve emotion recognition and everyday function.

Objective & Hypotheses. The objective of this randomized controlled trial is to determine the treatment effect of a MultiModal Affect Recognition Training (MMART) combined with attention training in Veterans with TBI/PTSD.

Hypothesis 1. MMART combined with attention training will significantly improve performance on tests of emotion recognition.

Hypothesis 2: Treatment gains will translate to functional activities. Primary measures. Florida Affect Battery (FAB) and the Community Reintegration in Service members (CRIS).

Secondary measures. Emotion Recognition Task (ERT), attention index of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Continuous Performance Task and the TBI Quality of Life (TBI-QOL) Ability to Participate in Social Roles and Activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Veterans with a diagnosis of mTBI and PTSD based on VA/Department of Defense guidelines.
  • Emotion recognition deficit
  • Attention deficit
  • Corrected vision within normal limits
  • Hearing within normal limits
  • Fluent in English

排除标准

  • Premorbid history of schizophrenia
  • Bipolar disorder
  • Chronic medical or neurological diseases

研究组 & 干预措施

MMART and attention training

Experimental

Training to recognize affect and prosodic expressions of emotions combined with attention training.

干预措施: Multimodal affect recognition training (Behavioral)

MMART and attention training

Experimental

Training to recognize affect and prosodic expressions of emotions combined with attention training.

干预措施: Attention Training (Behavioral)

Brain Health Workshop and National Geographic Movies

Placebo Comparator

an inactive arm that matches sessions of intervention. BHW is education about the brain and cognition. National Geographic movies are viewed with the clinician and the participant answers questions about the movies.

干预措施: Brain Health Workshop (Behavioral)

Brain Health Workshop and National Geographic Movies

Placebo Comparator

an inactive arm that matches sessions of intervention. BHW is education about the brain and cognition. National Geographic movies are viewed with the clinician and the participant answers questions about the movies.

干预措施: National Geographic Movies (Behavioral)

结局指标

主要结局

Community Reintegration of Service Members, assessing change

时间窗: week 1, week 11, week 22

Satisfaction questionnaire of community participation. Scores range from .43 to 2.15. 43 items with five rating options of 1-5. Higher scores indicate better community participation.

Florida Affect Battery (FAB), assessing change

时间窗: week 1, week 11, week 22

A standardized assessment of emotional affect and prosody recognition. normative scores range from 0-100 for each of the 12 subscales. Higher scores indicate better emotion recognition.

次要结局

  • Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing change(week 1, week 11, week 22)
  • Emotion Recognition Task, assessing change(week 1, week 11, week 22)
  • Continuous Performance Task, assessing change(week 1, week 11, week 22)
  • Traumatic Brain injury quality of life(week 1, week 11, week 22)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (2)

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